contains the history, regulations, types, advantages and disadvantages of respective topic are covered

1. Gayathri Tangirala
18PMM678
National Institute of Pharmaceutical Education &
Research, SAS Nagar.

2. Introduction OF DTCA
Goals of DTCA
History and Regulation of DTCA
Types of DTCA
Pro’s of DTCA
Con’s of DTCA
Conclusion
FLOW OF CONTENTSFLOW OF PRESENTATION
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3. 1Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/
INTRODUCTION
COUNTRIES INVOLVED
The U.S. and New Zealand
are the only countries that
allow DTCPA that includes
product claims
.
MEDIA INVOLVED
Appear on TV, Radio,
magazines, newspapers
and also online
OTHER NAME
Also known as DTCPA
.DEFINITION
DTCPA can be defined as an effort
made by a pharmaceutical
company to promote its
prescription products directly to
patients
.

4. Inform
consumers
about different
diseases
Inform
consumers
about different
treatment
options
Encourages
patients to visit
their primary
care physicians
Make doctors
and patients the
better partners
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GOALS OF DTCA
Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/

5. 3
DTCA In New Zealand
Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/
PRODUCTS REGULATED
Medicines,
Related products,
Herbal remedies,
Medical devices,
Controlled drugs used as
medicines
1st ADVERTISEMENT
Merck sharp and Dohme’s Proscar
(finasteride) a treatment for
benign prostatic hypertrophy, was
the first television aired DTC
advertisement in New Zealand
.
REGULATORY BODY
MEDSAFE is the New Zealand
medicines and medical
devices safety authority –
responsible for the regulation
of therapeutic products in
New Zealand
.
ACT & REGULATION
DTCA was permitted in New
Zealand under conditions set
by the Medicines Act (1981)
and Medicines Regulations
(1984)
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6. 4
DTCA In INDIA
Ministry of Health
and Family
Welfare(=U.S FDA)
and Central Drug
Standard Control
Organization(=U.S
CDER)
Laying down
standards for
drugs,
cosmetics,
diagnostics
and devices
Laying down
regulatory
measures ,
amendments
to acts and
rules
To regulate
market
authorization
of new drugs
Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/

7. 5
Cont.…
Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/
According to Drugs and Cosmetics act of 1940 and Drugs
and Magic remedies (Objectionable Advertisement
Act,1954 )
.
Control Advertisements regarding drugs
Prohibits advertisements of remedies alleged
to possess magic qualities
Prohibits Advertising of Rx drugs defined as Schedule H and
Schedule X drugs

8. HISTORY AND REGULATION
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HISTORY AND REGULATION
Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/

9. 7
The FDA’s Division of Drug Marketing, Advertising, and
Communications (DDMAC) is responsible for the regulation of DTCPA.
FINAL REGULATIONS
FOR PRESCRIPTION
DRUG ADVERTISING
NOT BE FALSE AND
MISLEADING
FAIR BALANCE OF
INFORMATION i.e.
RISKS AND BENEFITS
OF DRUG
MATERIAL TO
PRODUCTS
ADVERTISED USERS
BRIEF SUMMARY
ABOUT RISKS
DESCRIBED
Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/
Cont.…

10. TYPE OF
ADVERTISEMENT INCLUDES FAIR BALANCE MAJOR STATEMENT ADEQUATE PROVISION
PRODUCT CLAIM
ADVERTISEMENT
• Drug and the
indication(s)
• Makes claims
regarding safety
and efficacy
Required
Risks must be
included
Required for
brief access
REMAINDER
ADVERTISEMENT
• Drug
• Dosage form
• Cost
• Uses are not
included
Not required Not required Not required
HELP SEEKING
ADVERTISEMENT
• Describes a disease
or condition
• Drug name is not
mentioned
Not required • Not required Not required
8Source : https://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm082287.html
TYPES OF ADVERTISEMENTS

11. 9
THE REMAINDER ADVERTISEMENT
https://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm083573.html

12. 10
IMPACT ON CONSUMERS
Source: https://www.phrma.org/report/2017-direct-to-consumer-advertising-survey-results
Rating of prescription medicine
advertisements in providing information
Asking The Information About
Advertised Medicine
yes, 61%
no, 38%
Patients were asked whether they had
interacted with doctor regarding
advertisements

13. 11
YEARLY EXPENDITURE ON DTCA
Source: https://www.statista.com/statistics/686906/pharma-ad-spend-usa/
3.9
4.3
5.1
6.1
6.4
6.1
0
1
2
3
4
5
6
7
2012 2013 2014 2015 2016 2017
SPENDINGONDTCA
YEAR
Direct to consumer spending of pharmaceutical industry in Billion dollars

14. Informs, educates, and
empowers patients.
Encourages patients to contact
a clinician
Promotes patient dialogue
with health care providers.
Strengthens a patient’s
relationship with a clinician
Encourages patient compliance
Reduces under-diagnosis and
undertreatment of conditions
PRO’S OF DTCA
12Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/
PRO’S OF DTCA

15. Misinforms
patients.
Over
emphasizes
drug
benefits.
Promotes
new drugs
before safety
profiles are
fully known
Manufactures
disease and
encourages
drug over-
utilization
Leads to
inappropriate
prescribing
Increases
costs.
CON’S OF DTCA
13Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/
CON’S OF DTCA

16. • Effect of DTCPA on consumers is both positive and negative.
• An increased understanding of the effects of DTCPA will have important implications for public
health in the U.S. and New Zealand as well In other countries and regions where the ban on such
advertising is being challenged.
• Although a ban or severe curtailment of DTCPA has occasionally been called for in the U.S.,
remedies that will maximize the benefits and minimize the risks of DTCPA are more frequently
proposed.
• It is hoped that these measures will allow this controversial, but powerful, medium to be better
utilized for the improvement of public health.
CONCLUSION
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CONCLUSION